Stradis Orthopedic Split Drape Pack Recalled Due to Component Issue
Stradis Healthcare is recalling Orthopedic Split Drape Packs because they contain a Devon Light Glove component recalled by Medtronic.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes it as a precautionary action due to a component recall without reporting specific injuries, illnesses, or structural defects, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Orthopedic Split Drape Packs. These convenience kits are used during surgery and contain a Devon Light Glove component.
The recall is being conducted because the manufacturer of the component, Medtronic, has recalled the Devon Light Glove. The source text does not specify the exact nature of the defect or the specific hazard associated with the component.
The affected product is Pack 888-2604. Distribution was nationwide in the United States to specific states including AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WA, as well as to Canada and Dubai. The source text does not provide instructions for consumers or healthcare providers on how to handle the recalled product.
The recalled product
- Product
- Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Pack 888-2604
Distribution
Part of a larger recall action
This product is one of 51 recalled by Stradis Healthcare, LLC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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